510(k) K153064 ยท DZE Implant, Endosseous, Root-Form
Blue Sky Bio Zygomatic Implant System
| Applicant | Blue Sky Bio, LLC, Grayslake IL, US |
| Decision | Substantially Equivalent, Apr 29, 2016 |
| Received | Oct 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153064
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.